DelveInsight’s ’Antibody-Mediated Rejection (AMR) – Market Insights, Epidemiology, and Market Forecast?2030’ report deliver an in-depth understanding of the AMR, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The AMR market report provides current treatment practices, emerging drugs, and their market share of the individual therapies, current and forecasted AMR symptoms market size from 2017 to 2030 segmented by seven major markets. The report also covers current AMR symptoms treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities. It assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Study Period: 2017–2030
AMR Disease Understanding and Treatment Algorithm
AMR Overview
Antibody-mediated rejection (AMR) is a major cause of late kidney transplant failure. Antibody-mediated rejection (AMR), also known as B-cell-mediated or humoral rejection, is a significant complication after kidney transplantation that carries a poor prognosis. Although fewer than 10% of kidney transplant patients experience AMR, as many as 30% of these patients experience graft loss as a consequence. Although AMR is mediated by antibodies against an allograft and results in histologic changes in allograft vasculature that differ from cellular rejection, it has not been recognized as a separate disease process until recently. With an improved understanding of the importance of the development of antibodies against allografts as well as complement activation, significant advances have occurred in the treatment of AMR.
Many unmet needs are associated with this disorder; there is no approved standard of care, subtype distinctions are not clearly defined, and increased therapy toxicity. Therefore, it becomes imperative that such needs are fulfilled to have an efficient and reliable method to treat this disease.
AMR Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the AMR market for the treatment of the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The DelveInsight AMR market report gives a thorough understanding of AMR symptoms by including details such as disease definition, symptoms, causes, physiology, and diagnosis. It also provides AMR symptoms of treatment algorithms and treatment guidelines for AMR symptoms in the US, Europe, and Japan.
In concordance with these views, treatment protocols for AMR use permutations of a multiple-prong approach that include (1) the suppression of the T-cell dependent antibody response, (2) the removal of donor reactive antibody, (3) the blockade of the residual alloantibody, and (4) the depletion of naive and memory B-cells. Although all published protocols report a variable rate of success, a major weakness of all current protocols is the lack of effective anti-plasma cell agents.
AMR Epidemiology
The AMR symptoms epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings
The total incident cases of AMR is increasing by 7MM during the study period, i.e., 2017–2030.
The disease epidemiology covered in the report provides historical as well as forecasted AMR symptoms epidemiology segmented as the Transplant incidence of AMR, and Antibody-Mediated Rejection cases. The report includes the incident scenario of AMR symptoms in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
Country-wise AMR Epidemiology
The epidemiology segment also provides the AMR epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The total incident cases of AMR associated in 7MM countries was 5,283 in 2020.
AMR Drug Chapters
The drug chapter segment of the AMR report encloses the detailed analysis of AMR early-stage (Phase-I, II, III) pipeline drugs. It also helps understand the AMR clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
AMR Emerging Drug
Clazakizumab: CSL Behring
Clazakizumab is a potent, monoclonal antibody that binds to and inhibits IL-6, an important driver of the inflammatory response that is known to play a key role in transplant rejection. While advances in transplantation techniques and therapies have markedly improved short-term success rates over the past 15–20 years, long-term graft survival remains one of the greatest challenges, with AMR recognized as the most common cause of long-term kidney allograft failure.
Imlifidase: Hansa Biopharma
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically target IgG and inhibits IgG-mediated immune response. Using imlifidase is a novel approach to eliminate pathogenic IgG. It has a rapid onset of action, cleaving IgG-antibodies, and inhibiting their reactivity within hours after administration.
Products detail in the report?
AMR Market Outlook
The AMR market outlook of the report helps build a detailed comprehension of the historic, current, and forecasted AMR market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.
This segment gives a thorough detail of AMR market trend of each marketed drug and early-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, the AMR market in 7MM is expected to grow in the study period 2017–2030.
The primary aims of nearly all therapeutic approaches for AMR are removing circulating DSA and reducing DSA production. In this sense, the strongholds for contemporary treatment of AMR are represented by plasma exchange (PLEX) and IVIG, although neither of these has FDA approval. Over the last decade, the complement system has attracted increasing attention as an important contributor to AMR. The main goal of using complement inhibitors is to avoid the downstream damage to the allograft from DSA. Eculizumab is one such therapy that results in terminal complement blockade as a monoclonal antibody targeting C5.
Key Findings
This section includes a glimpse of the AMR market in 7MM. The market size of AMR in the seven major markets was USD 90.22 million in 2020.
The United States Market Outlook
This section provides the total AMR market size and market size by therapies in the United States.
The United States accounts for the largest market size of AMR in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
EU-5 Countries: Market Outlook
The total AMR market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total AMR market Size and market Size by therapies in Japan are also mentioned.
AMR Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017–2030. The analysis covers AMR market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs based on market share and size which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.
AMR Pipeline Development Activities
The report provides insights into the therapeutic candidate in Phase II and III stages. It also analyses AMR key players involved in developing targeted therapeutics.
Major players include CSL Behring, Hansa Biopharma, and Viela Bio.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for AMR emerging therapies.
Reimbursement Scenario in AMR
Approaching reimbursement, proactively, can have a positive impact both during the early stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
One US-based study estimated that the per-patient cost of AMR was USD 25,000 (2011 USD), based on the costs of biopsy, 3-day hospital stay, pulse steroids, IVIG (2 g/ kg), and rituximab (1 g). The same study also estimated a cost of USD 103,000 in the year of the event for patients who experienced graft loss due to AMR, the largest component of which was the cost associated with returning to dialysis. In 2011, Marfo and colleagues considered a similar treatment protocol based on costs associated with desensitization protocols in the US. The study assumed two high-dose IVIG infusions at 2 g/kg and a single dose of rituximab at 375 mg/m2 at a total cost per transplantation of USD 21,000. This cost was assumed for every transplantation conducted in sensitized patients rather than as an AMR treatment strategy, but the same procedure would be followed again in desensitized patients experiencing AMR. The authors noted that an additional USD 10,000 would be added to the total cost of desensitization in the case where plasmapheresis is indicated. A third US-based study estimated higher average costs of AMR events, with estimates ranging between USD 49,000 (based on biopsy, 2-day hospital stay, and treatment with IVIG plus rituximab) to USD 155,000 (based on 10 sessions of plasmapheresis, IVIG and 20 days in hospital; 2005–2006 USD).
KOL Views
To keep up with current market trends, we take KOLs and SME’s opinion working in the AMR domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or AMR market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the AMR Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of AMR, explaining its causes, signs and symptoms, physiology, and currently available therapies
- Comprehensive insight has been provided into the AMR epidemiology and treatment in the 7MM
- Additionally, an all-inclusive account of both the current and emerging therapies for AMR is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
- A detailed review of the AMR market; historical and forecasted is included in the report, covering drug outreach in the 7MM
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the global AMR market
Report Highlights
- In the coming years, the AMR market is set to change due to the rising awareness of the disease, and the Favorable Environment for New Anti-infective Modalities; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
- The companies and academics are working to assess challenges and seek opportunities that could influence AMR R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
- Major players are involved in developing therapies for AMR. The launch of emerging therapies will significantly impact the AMR market
- Our in-depth analysis of the pipeline assets across different stages of development (Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
AMR Report Insights
- Patient Population
- Therapeutic Approaches
- AMR Pipeline Analysis
- AMR Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
AMR Report Key Strengths
- 11 Years Forecast
- 7MM Coverage
- AMR Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
AMR Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
Key Questions
Market Insights:
- What was the AMR Market share (%) distribution in 2017 and how it would look like in 2030?
- What would be the AMR total market Size as well as market Size by therapies across the 7MM during the forecast period (2017–2030)?
- What are the key findings of the market across 7MM and which country will have the largest AMR market Size during the forecast period (2017–2030)?
- At what CAGR, the AMR market is expected to grow in 7MM during the forecast period (2017–2030)?
- What would be the AMR market outlook across the 7MM during the forecast period (2017–2030)?
- What would be the AMR market growth till 2030, and what will be the resultant market Size in the year 2030?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
- What are the disease risk, burdens, and unmet needs of the AMR?
- What is the historical AMR patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What would be the forecasted patient pool of AMR in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What will be the growth opportunities in the 7MM concerning the patient population about AMR?
- Out of all 7MM countries, which country would have the largest prevalent population of AMR during the forecast period (2017–2030)?
- At what CAGR the population is expected to grow in 7MM during the forecast period (2017–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of AMR along with the approved therapy?
- What are the current treatment guidelines for the treatment of AMR in the USA, Europe, and Japan?
- What are the AMR marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
- How many companies are developing therapies for the treatment of AMR?
- How many therapies are developed by each company for the treatment of AMR?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of AMR?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the AMR therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for AMR and its status?
- What are the key designations that have been granted for the emerging therapies for AMR?
- What are the global historical and forecasted market of AMR?
Reasons To Buy
- The report will help in developing business strategies by understanding trends shaping and driving the AMR market
- To understand the future market competition in the AMR market and Insightful review of the key market drivers and barriers
- Organize sales and marketing efforts by identifying the best opportunities for AMR in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
- Organize sales and marketing efforts by identifying the best opportunities for the AMR market
- To understand the future market competition in the AMR market